Food contact material compliance is not a single-test exercise. Exporters need to build market-specific evidence for the EU, US and ASEAN markets based on material type, intended use, substance authorization status and documentation requirements.
This article compares the main regulatory logic of the three markets and explains how exporters of food packaging, tableware, processing equipment parts and FCM-related raw materials can choose a practical compliance path.
Quick Navigation
Jump to the key regulatory comparison, market-specific requirements and practical compliance steps.
Food contact materials (FCMs) include materials and articles that may come into contact with food during production, packaging, storage, transportation, sale or use. Common examples include beverage bottles, takeaway containers, can coatings, ceramic tableware, sealing rings, coatings, printing inks, adhesives and food processing equipment components.
Food contact material compliance is not simply a matter of obtaining a single test report. Regulatory expectations differ significantly across markets. The European Union places strong emphasis on a structured legal framework, material-specific rules, migration limits, Good Manufacturing Practice (GMP), declarations of compliance and supply chain traceability. The United States focuses on whether a specific food contact substance has a lawful basis for a specific use and contact condition. ASEAN markets, meanwhile, are developing regional coordination while member states continue to apply their own national requirements.
Companies targeting Southeast Asian markets should assess ASEAN food contact materials compliance on a country-by-country basis. When food packaging, tableware, processing equipment parts or FCM-related raw materials are supplied to multiple markets, understanding these regulatory differences is essential for determining the correct compliance route.
EU, US and ASEAN Food Contact Materials Regulations at a Glance
| Compliance Dimension | European Union | United States | ASEAN |
|---|---|---|---|
| Regulatory model | Framework regulation, material-specific measures and member state requirements | FDA framework based on food contact substances and intended uses | ASEAN-level guidance and national regulations applied in parallel |
| Key legal basis | Regulation (EC) No 1935/2004, Regulation (EC) No 2023/2006, Regulation (EU) No 10/2011 and other measures | 21 CFR provisions, Food Contact Notifications (FCNs), Threshold of Regulation (TOR), GRAS and other applicable bases | ASEAN FCM principles, GMP guidance and national rules such as Indonesia BPOM food packaging requirements |
| Main compliance logic | Material category, positive lists, migration limits, GMP, declaration of compliance and traceability | Whether a substance is legally permitted for a specific food contact use | Country-by-country assessment based on local rules, material type, testing requirements and permitted substances |
| Key action for companies | Build an EU FCM compliance matrix and maintain supporting documentation | Confirm whether 21 CFR, FCN, TOR, GRAS or another basis applies | Identify target countries first, then assess national FCM requirements |
EU Food Contact Materials Regulations: A Structured and Documentation-Based System
The EU food contact materials framework is built around Regulation (EC) No 1935/2004, which applies to materials and articles intended to come into contact with food, already in contact with food, or reasonably expected to come into contact with food under normal or foreseeable conditions of use.
Under this framework, the EU has adopted specific measures for certain materials and risk areas. For example, Regulation (EC) No 2023/2006 sets out GMP requirements for food contact materials, while Regulation (EU) No 10/2011 provides detailed rules for plastic materials and articles, including authorized substances, specific migration limits and documentation requirements.
For plastic food contact materials, companies should pay particular attention to whether monomers, additives, polymer production aids and other components are listed or otherwise permitted under the applicable EU rules and restrictions.
EU FCM compliance typically involves more than migration testing. Companies may need to assess:
whether the product falls within the EU FCM regulatory scope;
which EU framework, material-specific and member state requirements apply;
whether substances comply with positive lists or use restrictions;
specific migration limits (SML), overall migration limits (OML), residual substances and non-intentionally added substances (NIAS);
whether a Declaration of Compliance (DoC) and supporting documentation are required;
whether information transfer and traceability obligations are properly managed across the supply chain;
whether non-plastic materials are subject to member state rules, industry guidance or relevant resolutions.
For multilayer materials, coated or printed food packaging, recycled plastic FCMs and complex food contact articles, companies should further assess each material layer, functional barriers, recycling sources, production processes and intended end uses.
US FDA Food Contact Materials Regulations: Substance-Specific and Use-Specific Compliance
In the United States, food contact materials are mainly regulated by the U.S. Food and Drug Administration (FDA). Compared with the EU, the US approach is less focused on a single unified material framework and more focused on whether a food contact substance is lawfully permitted for a specific use, food type and contact condition.
In practice, companies usually begin by checking whether the product or its components are covered by relevant provisions in Title 21 of the Code of Federal Regulations. For example:
21 CFR Part 175 covers adhesives and components of coatings;
21 CFR Part 176 covers paper and paperboard components;
21 CFR Part 177 covers polymers;
21 CFR Part 178 covers adjuvants, production aids and sanitizers used as indirect food additives.
If a substance or intended use is not clearly covered by 21 CFR, companies may need to evaluate other possible compliance routes, including:
Threshold of Regulation (TOR)
TOR may apply to certain food contact substances with very low dietary exposure, provided the relevant conditions are met. FDA's TOR inventory lists substances that have received exemptions for specified uses and restrictions.
Food Contact Notification (FCN)
An FCN may be required where a food contact substance needs FDA review based on safety, intended use and exposure data. Companies should note that an FCN is generally effective only for the manufacturer or supplier identified in the notification and for the specific use described.
GRAS or Other Existing Basis
In certain cases, Generally Recognized as Safe (GRAS) status or another regulatory basis may support the compliance assessment. However, this should be evaluated case by case according to the substance, use condition and applicable regulatory framework.
The key question for US FCM compliance is therefore not only whether a material is "safe", but whether each relevant substance has a defensible legal basis for the specific food contact use.
ASEAN Food Contact Materials Compliance: Why a Country-by-Country Assessment Is Needed
ASEAN has promoted regional alignment in food contact materials regulation. However, ASEAN has not established a single FCM market comparable to the EU system, nor has it adopted fully harmonized material-specific rules for all food contact materials.
As a result, companies should avoid relying on broad statements such as "compliant with ASEAN regulations" without identifying the target country. For ASEAN food contact materials compliance, the practical approach is usually country-by-country assessment.
For example, in Indonesia, food packaging materials are mainly regulated by BPOM. Companies may need to assess material categories, permitted substances, testing requirements and whether substances not listed in the applicable rules could trigger additional regulatory obligations. Other ASEAN member states may apply different levels of regulatory detail, testing expectations, documentation requirements and enforcement priorities. Some markets may also refer to EU, US or other international regulatory systems in practice.
For companies entering Southeast Asian markets, a practical ASEAN FCM assessment should include:
identifying the target country and intended use;
confirming the product's material category;
checking whether the country has material-specific rules, positive lists or testing standards;
assessing whether EU, US or other international references may be accepted or useful;
preparing test reports, composition information, supply chain declarations and use descriptions;
evaluating whether unlisted substances or special materials may require further assessment or authority communication.
Companies preparing to export food packaging or food contact materials to Southeast Asia may refer to REACH24H's ASEAN food contact materials compliance service guide for support with country-specific regulatory assessment, documentation review, testing strategy and market entry preparation.
How Exporters Can Build a Practical FCM Compliance Path
Companies selling the same food packaging material, tableware, processing equipment component or FCM raw material into the EU, US and ASEAN markets should not rely on a single test report as a universal compliance conclusion. Instead, companies are advised to build a compliance evidence chain based on product information, target markets, applicable regulations and technical documentation.
A practical assessment can follow five steps.
Step 1: Confirm Whether the Product Is a Food Contact Material
Companies should first determine whether the product may directly or indirectly contact food under normal or foreseeable conditions of use. This may include food packaging, containers, processing equipment components, seals, coatings, inks, adhesives or other materials used in the food supply chain.
Step 2: Define the Target Market and Intended Use
Compliance requirements may vary depending on where the product is placed on the market and how it is used. The same material may face different requirements when used for refrigerated storage, hot filling, microwave heating, long-term storage, fatty foods or infant food contact applications.
Step 3: Break Down Material and Formulation Information
A reliable FCM assessment requires information on starting substances, additives, production aids and other components used in the manufacturing process. For multilayer or composite materials, each layer and functional component may need to be assessed separately.
Step 4: Check the Applicable Legal Basis in Each Market
For the EU, companies should assess framework regulations, material-specific measures, positive lists and migration limits. For the US, companies should evaluate 21 CFR, FCNs, TOR, GRAS or other lawful bases. For ASEAN, companies should focus on the relevant member state's local regulations and regulatory practice.
Step 5: Prepare Market-Specific Compliance Documentation
After the assessment, companies should maintain documentation that supports the compliance conclusion for each target market. This may include declarations, test reports, formulation information, supplier statements, risk assessments and technical files.
Which Companies Should Prioritize Multi-Market FCM Compliance Assessment?
Multi-market FCM compliance assessment is particularly important for companies that:
export the same product to the EU, US and ASEAN markets;
manufacture multilayer packaging, coated materials, printed packaging, adhesives, inks or recycled materials;
use new additives, functional aids or substances with uncertain authorization status;
need to provide DoC, FDA compliance statements, test reports or technical support documents to customers;
supply brand owners, importers, distributors or downstream food businesses that require regulatory evidence.
Early assessment can help companies identify data gaps, avoid unsuitable testing strategies, clarify supply chain responsibilities and reduce uncertainty before market entry.
How REACH24H Can Support Food Contact Materials Compliance
REACH24H provides regulatory support for food contact materials across major global markets. Specific service items include:
EU FCM compliance assessment for framework, material-specific and documentation requirements;
US FDA food contact substance compliance route analysis, including 21 CFR, FCN, TOR, GRAS or other lawful bases;
ASEAN and member-state food packaging regulatory assessment for country-specific market entry requirements;
Testing strategy design based on material type, intended use and target market expectations;
Declaration of Compliance review and supporting documentation check;
Technical dossier preparation for regulatory assessment, customer audit and importer review;
Supply chain documentation support, including supplier statements and information transfer requirements.
For companies exporting food packaging and food contact materials to Southeast Asia, REACH24H can support country-specific regulatory assessment and market entry preparation.
Related Service
ASEAN FCM Compliance Service Guide
For companies exporting food packaging, food contact materials, coatings, inks, adhesives, plastic materials or related raw materials to Southeast Asian markets, REACH24H provides ASEAN FCM regulatory assessment, documentation review, testing strategy support and country-specific compliance route analysis.
Frequently Asked Questions
Is overall migration testing enough for EU food contact materials?
No. Overall migration testing may be one part of the assessment, especially for plastic food contact materials, but it is not sufficient on its own. Companies should also assess the applicable material category, positive lists, use restrictions, specific migration limits, heavy metals, primary aromatic amines, GMP, declaration of compliance and supporting documentation requirements.
What if a food contact substance is not clearly listed under US 21 CFR?
If a substance or intended use is not clearly covered by 21 CFR, companies may need to assess whether TOR, FCN, GRAS or another regulatory basis could apply. The correct route depends on the substance, exposure level, intended use, food type and contact condition.
Does ASEAN have one unified food contact materials regulation?
ASEAN has regional coordination initiatives and general guidance, but food contact materials are still mainly regulated by individual member states. Companies should identify the specific target country, such as Indonesia, Thailand, Vietnam or Singapore, and assess the applicable local rules, testing expectations and documentation requirements.
What information is usually needed for an FCM compliance assessment?
Companies typically need to provide product information, material composition, physicochemical properties, purity, intended use, food contact conditions, existing test reports and supplier documentation. Additional information may be needed for multilayer materials, recycled materials, coatings, inks, adhesives or unlisted substances.
Can one documentation package cover the EU, US and ASEAN markets?
A single base technical information package may be useful, but it usually cannot fully cover all three markets. Companies should prepare market-specific compliance conclusions and supporting documents based on the applicable EU, US and ASEAN member-state requirements.
Need to assess food packaging compliance for multiple markets?
REACH24H can help exporters review formulation information, identify applicable compliance routes and prepare market-specific documentation for the EU, US and ASEAN markets.
浙公网安备 33011002014301号